510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K020004Substantially Equivalent

Clindatalink Version 1.0 for Spirometry

Compleware Corp., Iowa City IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020004 is the FDA 510(k) clearance record for CLINDATALINK VERSION 1.0 FOR SPIROMETRY, a class II device, cleared for Compleware Corp. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for Compleware Corp. As of , FDA records show no recalls naming K020004.

Clearance record

Decision date
Received
(203 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Compleware Corp. 221 E. Burlington St., Iowa City IA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZG

Trailing 12 months
1 clearance under product code BZG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260